Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes

Recurrent Patellar Dislocation Clinical Trial

Official title:

Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes - rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene in Patellar Instability in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05763108
• Other study ID #: PMMHRI-2021.2/1/7-GW
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: December 20, 2023

Study information

• Verified date: October 2022
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess correlation between recurrent patella dislocation and genetic polymorphism rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene.

Description:

After being informed about the study and potential risk all of participants were performed phisical examination and genetic test. In the study we established two groups: In first group- 50 patients with recurrent patellar dislocation and without any genetic disorders. In the second one 200 patients without recurrent patellar dislocation and genetic disorders. All pediatric patients were between 7 and 17 years old in two groups respectivly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 20, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.

Exclusion Criteria:

• Patient's age under 7.
• Presence of genetic diseases such as: Down's syndrome or Marfan's syndrome.
• Metabolic disorders.
• Previous knee surgeries.
• Cartilage and bone fractures in the knee.
• No consent for examination from the legal guardian.

Related Conditions & MeSH terms

• Ligament; Laxity
• Patellar Dislocation
• Recurrent Patellar Dislocation

Intervention

Diagnostic Test:
• genetic test
COL1A1 or COL5A1 genetic test

Other:
• Beighton joint laxity test
Based on Beighton scale.

Locations

Country	Name	City	State
Poland	Krzysztof Malecki	Lodz	Lodzkie Voivodeship
Poland	Krzysztof Malecki	Lódz	Lodzkie Voivodeship

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with recurrent patellar dislocation	Patients with recurrent patellar dislocation	2022-2023
Primary	Control group without obvious joint hipermobility	Control group without obvious joint hipermobility	2022-2023